Post Mastectomy LymphedemaNCT07019311
Effect of Thera-Band Versus Swiss Ball Exercises on Postural Stability in Post Mastectomy Lymphedema
A study testing Thera-Band exercises, Swiss ball exercises and Traditional physical therapy program in people with Post Mastectomy Lymphedema, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of the study is to determine the effect of Thera-band exercises versus Swiss ball exercises on postural stability in unilateral post mastectomy lymphedema. Read more about this study
- Who is it for?
- Ages 30 to 50 years, women only
- Conditions the study is for
- Post Mastectomy Lymphedema
- What is being tested?
- Thera-Band exercises, Swiss ball exercises and Traditional physical therapy program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Jun 2025to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients are females.
- Patient with post mastectomy unilateral lymphedema.
- Their age will range from (30-50) years.
- Patients will be given their informed consent.
Who cannot join
- Musculoskeletal disorders that will impair performance during training and tests.
- Uncontrolled cardiovascular or pulmonary diseases.
- Neurological and renal disorders.
- Metabolic or vascular disease with a neurological component such as diabetes.
- Malignant conditions.
- Primary lymphedema.
Show all 9Show fewer
- Psychiatric illness, severe behavior or cognitive disorders.
- Uncooperative patients.
- Pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Khadra Mohamed Ali, PhD contact
Egypt1 site
Damanhour Oncology Center
Damanhūr
Afkar Zaki Abdallah Elbabouby, M.Sc, +20 100 331 2524, dr.afkar.albanoby2016@gmail.com
About this study
The purpose of the study is to determine the effect of Thera-band exercises versus Swiss ball exercises on postural stability in unilateral post mastectomy lymphedema.
Read the detailed description
The need for this study develops from the lack of information in the published studies about the effectiveness of Thera-band exercises and Swiss ball exercise on balance in unilateral post mastectomy lymphedema.
Lymphedema is a chronic and progressive condition associated with functional impairment of the body segment.
The asymmetry between hemi Corp related to the range of motion, muscle strength, sensory stimuli and volume, reduce the ability to perceive and integrate information on the maintenance of the center of gravity and postural balance.
The damage in the balance of patients with breast cancer is pointed out in the literature and is related to factors related to surgical intervention, adjuvant treatment, or even unilateral asymmetry caused by upper limb lymphedema.
Core stability exercises improve neuromuscular system performance that causes the optimal lumbar-pelvic -hip chain mobility and good acceleration and deceleration, appropriate muscular balance, proximal stability and good function.
Progressive resistance training interventions designed to increase strength and reduce the falls in elderly were effective in reducing both rate of falls and risk of falling, especially when some form of balance exercise was an integral part of the program.
The present study is designed to investigate the effect of Thera-band exercises versus Swiss ball exercises on balance in unilateral post mastectomy lymphedema.
- Conditions
- Post Mastectomy Lymphedema
- Being tested
- Thera-Band exercises, Swiss ball exercises, Traditional physical therapy program
- Medical subject headings
- Breast Cancer Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thera-Band exercisesOther
Participants in the first experimental group performed a Thera-Band exercise program 3 sessions weekly, for 8 weeks with progressive resistance, divided into four 2-week phases. Each 60-minute session included a 10-min warm-up (walking, jogging, and calisthenics), 45-min Thera-Band exercises, and 5-min cool-down. Phase 1 focused on major muscle groups (e.g., shoulder press, biceps curl). Phase 2 included trunk and leg-focused moves (e.g., reverse flies, lunge). Phase 3 added advanced resistance (e.g., chest press, deadlift). Phase 4 targeted core and lower body (e.g., diagonal chop, squat). Exercises changed every phase to progressively strengthen different muscle groups.
Swiss ball exercisesOther
Participants in the second experimental group performed Swiss ball exercises 3 sessions weekly, for 8 weeks. Exercises included warm-up (15-5 mins), core Swiss ball training (progressing from 1 to 4 sets), and cool-down. Each session focused on abdominal, back, leg, trunk, and balance training using varied exercises performed for 30 seconds with rest. Exercise intensity ranged from 80-95% of max effort, increasing weekly. The Swiss ball size was selected based on patient height to ensure proper posture. Sessions gradually increased in duration and difficulty, ending with breathing and stretching for recovery.
Traditional physical therapy programOther
Participants in both experimental groups performed a traditional physical therapy program in the form of complex decongestive physical therapy(CDPT), including (manual lymphatic drainage, compression, exercise and skin care) and balance training, 3 sessions weekly, for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Thera-Band exercises + Traditional physical therapy program | Experimental | This group will consist of 32 patients with unilateral lymphedema following mastectomy. Participants will perform Thera-Band resistance exercises in addition to a traditional physical therapy program, 3 times per week for eight consecutive weeks. Receives: Other: Thera-Band exercises; Other: Traditional physical therapy program |
| Swiss ball exercises + Traditional physical therapy program | Experimental | This group will consist of 32 patients with unilateral lymphedema following mastectomy. Participants will perform Swiss ball exercises in addition to a traditional physical therapy program, 3 times per week for eight consecutive weeks. Receives: Other: Swiss ball exercises; Other: Traditional physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Center of Pressure (COP)
The Wii Balance Board (WBB) will be used to measure the Center of Pressure (COP), which represents the point location of the vertical ground reaction force vector. This outcome reflects the user's weight distribution and is a key indicator of balance and postural control. COP will be assessed in both the mediolateral (X-axis: left-right) and anteroposterior (Y-axis: front-back) directions, allowing evaluation of postural sway and dynamic weight shifting during balance tasks.
Measured: 8 weeks
Total Force (Weight)
Total vertical ground reaction force will be calculated by summing the readings from all four pressure sensors on the WBB. This measure provides an estimate of the user's body weight and enables monitoring of force fluctuations during dynamic or static postural tasks, serving as an indirect marker of load-bearing and movement initiation or compensation patterns.
Measured: 8 weeks
Load Distribution
The WBB will quantify the distribution of body weight across the left vs. right and front vs. back regions of the platform. This load distribution outcome helps identify asymmetries in stance or postural alignment, which can be critical in populations with balance deficits or musculoskeletal impairments. The measure allows for detailed analysis of postural strategy and weight-bearing preference.
Measured: 8 weeks
Secondary outcomes (1)
Limb volume measurement
Limb volume will be measured using the truncated cone method with circumferential measurements taken at 10-cm intervals (at 0, 10, 20, 30, and 40 cm from the ulnar styloid). The patient will be seated with the limb supported horizontally on a bedside table. A 1-cm retractable fiberglass tape will be used, and an adhesive measuring strip from axilla to wrist will ensure consistency. Segment volume will be calculated using the formula: V = h × (C1² + C1×C2 + C2²) / (12π), where C1 and C2 are the circumferences and h is the 10 cm distance between them.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start11 Jun 2025 (estimated)
- Primary completion11 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Mastectomy LymphedemaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Afkar Zaki Abdullah Elbanouby, Cairo University
- Investigators
- Mohammed Mahmoud Abdelkhalek Khalaf, Study chair, Professor, Cairo universityKhadra Mohamed Ali, Study director, Assistant Professor, Cairo universityEid Rizk El Gammal, Study director, Assistant Professor, Al-Azhar university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07019311
- Sponsor's protocol ID
- P.T.REC/012/005215
- Status last verified
- Jun 2025
- First submitted
- 5 Jun 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Thera-Band Versus Swiss Ball Exercises on Postural Stability in Post Mastectomy Lymphedema
- ClinicalTrials.gov ID
- NCT07019311
- Acronym / sponsor ID
- P.T.REC/012/005215
- Conditions
- Post Mastectomy Lymphedema
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 11 Jun 2025 (estimated)
- Primary completion
- 11 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine the effect of Thera-band exercises versus Swiss ball exercises on postural stability in unilateral post mastectomy lymphedema.
Detailed description
The need for this study develops from the lack of information in the published studies about the effectiveness of Thera-band exercises and Swiss ball exercise on balance in unilateral post mastectomy lymphedema.
Lymphedema is a chronic and progressive condition associated with functional impairment of the body segment.
The asymmetry between hemi Corp related to the range of motion, muscle strength, sensory stimuli and volume, reduce the ability to perceive and integrate information on the maintenance of the center of gravity and postural balance.
The damage in the balance of patients with breast cancer is pointed out in the literature and is related to factors related to surgical intervention, adjuvant treatment, or even unilateral asymmetry caused by upper limb lymphedema.
Core stability exercises improve neuromuscular system performance that causes the optimal lumbar-pelvic -hip chain mobility and good acceleration and deceleration, appropriate muscular balance, proximal stability and good function.
Progressive resistance training interventions designed to increase strength and reduce the falls in elderly were effective in reducing both rate of falls and risk of falling, especially when some form of balance exercise was an integral part of the program.
The present study is designed to investigate the effect of Thera-band exercises versus Swiss ball exercises on balance in unilateral post mastectomy lymphedema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thera-Band exercises + Traditional physical therapy program | Experimental | Other: Thera-Band exercises, Other: Traditional physical therapy programThis group will consist of 32 patients with unilateral lymphedema following mastectomy. Participants will perform Thera-Band resistance exercises in addition to a traditional physical therapy program, 3 times per week for eight consecutive weeks. |
| Swiss ball exercises + Traditional physical therapy program | Experimental | Other: Swiss ball exercises, Other: Traditional physical therapy programThis group will consist of 32 patients with unilateral lymphedema following mastectomy. Participants will perform Swiss ball exercises in addition to a traditional physical therapy program, 3 times per week for eight consecutive weeks. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients are females.
- Patient with post mastectomy unilateral lymphedema.
- Their age will range from (30-50) years.
- Patients will be given their informed consent.
Key exclusion criteria (9 listed)
- Musculoskeletal disorders that will impair performance during training and tests.
- Uncontrolled cardiovascular or pulmonary diseases.
- Neurological and renal disorders.
- Metabolic or vascular disease with a neurological component such as diabetes.
- Malignant conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thera-Band exercisesParticipants in the first experimental group performed a Thera-Band exercise program 3 sessions weekly, for 8 weeks with progressive resistance, divided into four 2-week phases. Each 60-minute session included a 10-min warm-up (walking, jogging, and calisthenics), 45-min Thera-Band exercises, and 5-min cool-down. Phase 1 focused on major muscle groups (e.g., shoulder press, biceps curl). Phase 2 included trunk and leg-focused moves (e.g., reverse flies, lunge). Phase 3 added advanced resistance (e.g., chest press, deadlift). Phase 4 targeted core and lower body (e.g., diagonal chop, squat). Exercises changed every phase to progressively strengthen different muscle groups. | Other | Thera-Band exercises + Traditional physical therapy program |
| Swiss ball exercisesParticipants in the second experimental group performed Swiss ball exercises 3 sessions weekly, for 8 weeks. Exercises included warm-up (15-5 mins), core Swiss ball training (progressing from 1 to 4 sets), and cool-down. Each session focused on abdominal, back, leg, trunk, and balance training using varied exercises performed for 30 seconds with rest. Exercise intensity ranged from 80-95% of max effort, increasing weekly. The Swiss ball size was selected based on patient height to ensure proper posture. Sessions gradually increased in duration and difficulty, ending with breathing and stretching for recovery. | Other | Swiss ball exercises + Traditional physical therapy program |
| Traditional physical therapy programParticipants in both experimental groups performed a traditional physical therapy program in the form of complex decongestive physical therapy(CDPT), including (manual lymphatic drainage, compression, exercise and skin care) and balance training, 3 sessions weekly, for 8 weeks. | Other | Swiss ball exercises + Traditional physical therapy program, Thera-Band exercises + Traditional physical therapy program |
Primary outcome
Center of Pressure (COP)
Time frame: 8 weeks
The Wii Balance Board (WBB) will be used to measure the Center of Pressure (COP), which represents the point location of the vertical ground reaction force vector. This outcome reflects the user's weight distribution and is a key indicator of balance and postural control. COP will be assessed in both the mediolateral (X-axis: left-right) and anteroposterior (Y-axis: front-back) directions, allowing evaluation of postural sway and dynamic weight shifting during balance tasks.
Total Force (Weight)
Time frame: 8 weeks
Total vertical ground reaction force will be calculated by summing the readings from all four pressure sensors on the WBB. This measure provides an estimate of the user's body weight and enables monitoring of force fluctuations during dynamic or static postural tasks, serving as an indirect marker of load-bearing and movement initiation or compensation patterns.
Load Distribution
Time frame: 8 weeks
The WBB will quantify the distribution of body weight across the left vs. right and front vs. back regions of the platform. This load distribution outcome helps identify asymmetries in stance or postural alignment, which can be critical in populations with balance deficits or musculoskeletal impairments. The measure allows for detailed analysis of postural strategy and weight-bearing preference.
1 secondary outcome
Limb volume measurement
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
Related trials for Post Mastectomy Lymphedema
Recruiting
Effect of Resisted Deep Breathing and Myofascial Release in Postmastectomy
Post Mastectomy Lymphedema
Enrolling by invitation
Ultrasound-Guided Percutaneous Cryoneurolysis to Treat Postoperative Pain After Mastectomy
Mastectomy; Lymphedema
Recruiting
Pectoral Nerve Block Versus Paravertebral Block In The Incidence of Chronic Pain After Breast Cancer Surgery
Paravertebral Block, Pectoral Nerve Block
Active, not recruiting
Manual Lymphatic Drainage With Diaphragmatic Breathing Exercises in Post Radical Mastectomy
Breast Cancer Related Lymphedema
Recruiting
Erector Spinae Block Versus Paravertebral Block on Chronic Pain After Mastectomy
Mastectomy; Lymphedema, Chronic Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Khadra Mohamed Ali, PhD contact
Mohammed Mahmoud Abdelkhalek Khalaf study chair
Professor, Cairo university
Khadra Mohamed Ali study director
Assistant Professor, Cairo university
Eid Rizk El Gammal study director
Assistant Professor, Al-Azhar university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thera-Band exercises, Swiss ball exercises and Traditional physical therapy program in people with Post Mastectomy Lymphedema, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Afkar Zaki Abdallah Elbabouby, M.Sc (+20 100 331 2524, dr.afkar.albanoby2016@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Center of Pressure (COP) (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.